(57 days)
Not Found
Micro Hematocrit Centrifuge
Operations Manual
Battery Charger
100 Micro Capillary/Micro Capillary Holders (heparinized)
General Laboratory Device
Methodology: Centrifugal
Measures Hematocrit
Battery Operated
Portable, Hand-Held
Safety Features: (1) Cover Lock (2) Low Battery Charge Indicator (3) Motor failure indicator
Optically read (digital readout)
Uses plastic disposable
Range 14% to 57%
Operates at 10,000 RPM
RCF= 4260
Rotor Radius= 1.5 inches
Here's a breakdown of the acceptance criteria and study information for the Spuncrit™ device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state formal "acceptance criteria" in a numerical or pass/fail format for specific performance metrics. Instead, it presents performance data in comparison to a predicate device (Compur M1100 Minicentrifuge) and demonstrates precision. The "conclusion" section suggests that the device's performance is deemed "substantially equivalent" to the predicate, implying that its performance within the tested ranges is acceptable.
Assuming "substantial equivalence" is the overarching acceptance criterion, we can infer performance targets from the predicate device specifications and the presented data.
| Performance Metric | Acceptance Criteria (Inferred from Predicate/Substantial Equivalence) | Reported Device Performance (Spuncrit™) |
|---|---|---|
| Measurement Range (Hematocrit) | 10% to 80% (Predicate's range) | 14% to 57% (Device's calibrated range) |
| Measurement Range (Estimated Hemoglobin) | Not explicitly stated for predicate but likely similar clinical utility as hematocrit. | 12.2 g/dL to 18.2 g/dL (Normal range only) |
| Methodology | Centrifugal | Centrifugal |
| Readout Type | Manual, visual read (Predicate) | Optically read (digital readout) |
| Speed (RPM) | 11,500 RPM (Predicate) | 10,000 RPM |
| Relative Centrifugal Force (RCF) | 5396 (Predicate) | 4260 |
| Rotor Radius | 1.5 inches (Predicate) | 1.5 inches |
| Precision (Within-Run) - Hematocrit | Not explicitly defined as acceptance criteria, but predicate performs acceptably. | Physician Office #1 (Day 1): Level 1 SD 0.26, Cv 0.01; Level 2 SD 0.94, Cv 0.03; Level 3 SD 1.03, Cv 0.02Physician Office #1 (Day 7): Level 1 SD 0.77, Cv 0.04; Level 2 SD 0.63, Cv 0.02; Level 3 SD 0.63, Cv 0.02Physician Office #2 (Day 1): Level 1 SD 0.70, Cv 0.04; Level 2 SD 0.52, Cv 0.02; Level 3 SD 0.74, Cv 0.02Physician Office #2 (Day 7): Level 1 SD 0.64, Cv 0.04; Level 2 SD 0.59, Cv 0.02; Level 3 SD 0.59, Cv 0.01Alternate Site #3 (Day 1): Level 1 SD 0.51, Cv 0.03; Level 2 SD 0.88, Cv 0.02; Level 3 SD 1.11, Cv 0.02Alternate Site #3 (Day 7): Level 1 SD 0.68, Cv 0.04; Level 2 SD 0.51, Cv 0.02; Level 3 SD 0.52, Cv 0.01Laboratory (Day 1): Level A SD 0.32, Cv 0.02; Level B SD 0.48, Cv 0.02; Level C SD 0.48, Cv 0.02; Level D SD 0.58, Cv 0.01; Level E SD 0.68, Cv 0.01Laboratory (Day 13): Level A SD 0.52, Cv 0.04; Level B SD 0.67, Cv 0.02; Level C SD 0.92, Cv 0.02; Level D SD 1.51, Cv 0.02; Level E SD 0.52, Cv 0.01 |
| Precision (Between-Run) - Hematocrit | Not explicitly defined as acceptance criteria. | Physician Office #1: Level 1 SD 0.92, Cv 0.05; Level 2 SD 1.13, Cv 0.04; Level 3 SD 0.07, Cv < 0.01Physician Office #2: Level 1 SD 0.35, Cv 0.02; Level 2 SD 0.56, Cv 0.02; Level 3 SD 1.13, Cv 0.02Alternate Site Blood Bank #3: Level 1 SD 0.14, Cv 0.01; Level 2 SD 0.21, Cv 0.01; Level 3 SD 0.14, Cv < 0.01 |
| Correlation with Predicate (R) | High correlation (implied by substantial equivalence). | R = 0.99 for all comparative studies |
2. Sample Size Used for the Test Set and Data Provenance
- Comparative Studies (Performance/Effectiveness Information):
- Sample Size: A total of 45 whole blood samples were used for each of the four comparative study locations (Laboratory, Physician Office #1, Physician Office #2, Alternate Site/Blood Bank). Each location ran 15 samples at each of three levels (below normal, normal, upper normal). This means 180 total samples were run for comparative analysis (4 locations * 45 samples/location).
- Data Provenance: The document does not explicitly state the country of origin. The studies were conducted in "a typical laboratory," "Physician Office #1," "Physician Office #2," and a "Blood Bank." Given the submission is to the US FDA, it's highly probable the data is from within the United States. The studies described are prospective in nature, as they involved actively running samples to test the new device against the predicate.
- Precision Studies:
- Within-Run Precision:
- Physician Offices & Blood Bank: For each of the three sites, data was collected on Day 1 and Day 7. On each day, 15 samples were processed per each of three control levels, totaling 45 samples per day per site. So, 270 samples were analyzed for this part of precision (3 sites * 2 days * 3 levels * 15 samples/level).
- Laboratory: 10 whole blood samples were run at each of five levels on Day 1 and Day 13. This totals 100 samples (2 days * 5 levels * 10 samples/level).
- Between-Run Precision: This uses the data from the "within-run" studies across the two days of testing.
- Data Provenance: Similar to the comparative studies, likely United States and prospective.
- Within-Run Precision:
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not explicitly mention "experts" in the context of establishing ground truth for the test set.
- For the comparative studies, the predicate device (Compur M1100 Minicentrifuge) served as the reference standard. The results from the Compur M1100 were used to compare against the Spuncrit™.
- For the precision studies, assayed whole blood controls (from Streck Laboratories, Lot Numbers 61410065, 61410066, and 61410067) were used. The hematocrit values for these controls (e.g., 16 +/- 3) effectively served as the "ground truth" or target values. These controls are manufactured with established values.
The personnel operating the devices included a "technician running the Spuncrit" in the laboratory setting, "nurse running Spuncrit" in physician offices, and a "Phlebotomist running the Spuncrit" in the blood bank. Their qualifications are mentioned to indicate typical users but not as ground truth experts.
4. Adjudication Method for the Test Set
No explicit adjudication method is described. The comparison is made directly between the Spuncrit™ readings and the Compur M1100 readings (for comparative effectiveness) or against the established values of assayed controls (for precision). There's no mention of multiple human readers independently assessing results or an adjudication process for discrepancies.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The study focuses on comparing the device performance (Spuncrit™ vs. Compur M1100), not on how human readers (or their performance) are influenced by the Spuncrit™ technology. The Spuncrit™ has an optical/digital readout, which inherently reduces reader variability compared to the predicate's manual/visual read. However, this is a feature of the device, not an AI assistance for human readers as conceptualized in an MRMC study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the studies presented are essentially standalone performance evaluations of the Spuncrit™ device. While humans operate the device (technician, nurse, phlebotomist), the device itself (with its optical digital readout)
generates the result. The performance data (correlation with predicate, precision) reflects the device's capability directly, independent of subjective human interpretation after the device has processed the sample. The "optically read (digital readout)" feature strongly supports this as it automates the reading process that was manual on the predicate.
7. The Type of Ground Truth Used
- Comparative Studies: The ground truth was effectively established by the predicate device (Compur M1100 Minicentrifuge). The assumption is that the predicate device provides clinically acceptable hematocrit measurements.
- Precision Studies: The ground truth was established by assayed whole blood controls with known standard values (e.g., 16 +/- 3). This is a form of reference standard materials.
8. The Sample Size for the Training Set
The document describes studies for validation and substantial equivalence, not for training a specific algorithm or AI model. Therefore, there is no explicit "training set" mentioned in the context of device development or performance evaluation. The device being tested, the Spuncrit™ (Model DRC-40), is a hematocrit centrifuge with an optical digital readout, rather than an AI-powered diagnostic system that would require a separate training phase.
9. How the Ground Truth for the Training Set Was Established
Since no training set for an AI/algorithm is described, this question is not applicable to the provided document. The Spuncrit™ is a physical medical device for centrifuging blood and optically reading hematocrit, not an AI software.
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174 57 196 16:16 MICRO DIAGNOSIICS
Image /page/0/Picture/1 description: The image shows a logo with the letters MDC in a bold, stylized font. The letters are large and take up most of the image. To the right of the letters, there is the word "Mic" in a smaller font. The logo appears to be for a company or organization with the initials MDC.
Image /page/0/Picture/2 description: The image shows a sequence of numbers and a letter, specifically 'K961803'. The characters are written in a bold, sans-serif font, and they appear to be handwritten or drawn with a thick marker. The numbers and letter are evenly spaced and aligned horizontally.
Tics Cornorati
JUL - 5 1996
June 21, 1996
PAGE A
Food and Drug Administration Center for Devices and Radiological Health Office of Device Evaluation Document Mail Center (HFZ-401) 9200 Corporate Blvd Rockville MD 20850
K961803, Submission 510(k) Summary for Spuncrit™ RE:
Dear Sir or Madam:
A summary of the safety and effectiveness information upon which substantial equivalence is based as follows:
CLASSIFICATION :
Class II Hematocrit Centrifuge
PROPRIETARY NAME:
Spuncrit™ (Model DRC-40)
PRODUCTS UPON WHICH SUBSTANTIAL EQUIVALENCE IS BASED:
o Compur MI100 Minicentrifuge FDA No. K850391 Date: May 10, 1985
SIMILARITIES TO PREDICATE DEVICES CURRENTLY ON THE US MARKET
A) Predicate's Name and Manufacturer Address
Hematocrit
o Compur Millo Hematocrit System Bayer Diagnostic + Electronic GmbH Steinerstrasse 15 8000 Muchen 70 Germany C/O Hans J. Brouwers and Associates Box 823 Mt Prospect, IL 60056 FDA Reference No. K850391
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ﺮ
P.5715
PAGE B
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
| A1) | Comparison of Spuncrit™ to Compur (Predicate Device) | |
|---|---|---|
| MICRO DIAGNOSTICSSPUNCRIT™ | COMPURM1100 | |
| o Micro HematocritCentrifuge | o Micro HematocritCentrifuge | |
| o Operations Manual | o Operation Manual | |
| o Battery Charger | o Battery Replacement | |
| o 100 Micro Capillary/Micro CapillaryHolders (heparinized) | o 100 Capillaries(heparinized) | |
| A2 ) | The general features of the Spuncrit™ (Model DRC-40) ascompared to the Compur M1100 Minicentrifuge. | |
| SPUNCRIT™ | COMPUR M1100 | |
| o General LaboratoryDevice | o General LaboratoryDevice | |
| o Methodology:Centrifugal | o Methodology:Centrifugal | |
| o Measures Hematocrit | o Measure Hematocrit | |
| o Battery Operated | o Battery Operated | |
| o Portable, Hand-Held | o Portable, Hand-held | |
| Safety Features: | Safety Features : | |
| (1) Cover Lock | (1) Cover Lock | |
| (2)Low Battery ChargeIndicator | (2)Low Battery ChargeIndicator | |
| (3) Motor failure indicator | (3) No such feature | |
| o Optically read(digital readout) | o Manual, visual read |
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| 44 | |
|---|---|
| -- | -------- |
o Uses plastic disposable
o Range 14% to 57% ·
o Operates at 10,000 RPM
o RCF= 4260
o Rotor Radius= 1.5 inches
- o Uses qlass disposable
o Range 10% to 80%
o Operates at 11,500 RPM
o RCF=5396
o Rotor Radius= 1.5 inches
The safety features of the Spuncrit™ as compared to the Compur A3) M1100 Minicentrifuge.
SPUNCE IT IN
COVER LOCK
Mechanical lock switch which prevents cover from being opened while centrifuge is in operation
MECHANICAL BRAKE
In the event the cover is opened prior to the Spuncrit completing the 150 second cycle time the rotor automatically is braked, stopping its rotation within a few seconds
LOW BATTERY CHARGE
Digital display reads out "C" indicating to operator to charge batteries
INSTRUMENT MALFUNCTION
In the event of an electronic failure within the instrument the digital readout will not display "8's", as the DRC-40 is running.
COMPUR M1100
COVER LOCK
Mechanical lock switch which prevents cover from being opened while centrifuge is in operation
MECHANICAL BRAKE
No such feature
LOW BATTERY CHARGE
An illuminated red LED indicates batteries need to be replaced
INSTRUMENT MALFUNCTION
No such feature
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PAGE D
- Comparative data (Performance/Effectiveness Information) A4 } between the Spuncrit™ (Model DRC-40) and Compur's MILO Minicentrifuge.
RESULTS OBSERVED WHEN OPERATING THE SPUNCRIT
COMPARISON DATA
An "In Service" to explain the operation of the Spuncrit was performed in each of the locations. Approximately 10 minutes were utilized for training of persons operating the Spunctic a nhe comparative study at each location included a total of 45 whole blood samples encompassing three levels ranging from below the normal range to the upper level of the normal range . The samples were split such that each location ran 15 samples at each level.
Spunctit operating in a Laboratory:
- o Typical laboratory with technician running the Spuncrit
- N = 45 Range = 14% Hot to 49% Hot R = . 99
Spuncrit operating in Physician Office - #1
- o Physician Office employs six Physicians with nurse running Spuncrit.
- N = 45 Range = 14% Hot to 49% Hot R = . 99
Spuncrit operating in Physician Office - #2
- o Physician Office employs twelve physicians with a nurse running Spuncrit
N = 45 Range = 19% Het to 53% Hot R = . 99
Image /page/3/Figure/16 description: The image is a graph titled "Spuncrit vs Compur" and subtitled "Laboratory vs Laboratory". The graph shows a positive correlation between the two variables. The x-axis is labeled "Volat Spuncrit" and the y-axis is labeled "% Volat Compur". The data points on the graph are approximately (15, 15), (40, 60), and (50, 70).
Image /page/3/Figure/18 description: This image is a graph titled "Spuncrit vs Compur". The graph plots '% Hot Compur' on the y-axis and 'Site Spunart' on the x-axis. The graph shows a positive correlation between the two variables. The data points on the graph are approximately (10, 15), (40, 60), and (50, 75).
Image /page/3/Figure/20 description: The image shows a graph titled "Spuncrit vs Compur", which compares Physician Office #2 (Spuncrit) vs Laboratory (Compur). The x-axis is labeled "% Hot Spuncrit" and the y-axis is labeled "% Hot Compur". A line is plotted on the graph, and the equation for the line is given as y = 0.7 + 0.96x.
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SBungrit operating in an Alternate Sitei
- o Blood Bank with a Phlebotomist running the Spuncrit.
N = 45
- Range = 14% Hot to 49% Hot R = . 99
Image /page/4/Figure/7 description: The image shows a graph titled "Spuncrit vs Compur". The x-axis is labeled "%Hct Spuncrit" and ranges from 10 to 60. The y-axis is labeled "% Hct Compur" and ranges from 10 to 60. There is a line plotted on the graph that shows a positive correlation between the two variables.
Image /page/4/Figure/8 description: The image contains text that describes the data points in a study. Each data point represents an average of 15 whole blood samples. This suggests that the data presented is based on a collection of blood samples, and each point is an average value calculated from those samples. This information is important for understanding the methodology and scope of the study.
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inn 27 796 16:20 MICRO DIAGNOSTICS
PAGE P
PRECISION DATA
The precision study was performed within the physician office and another alternate site;a blood bank. Assayed whole blood controls were used in the precision study. Three levels of controls were used. A total of fifteen(15) samples were processed per each level for a total of 45 samples. The range varied from below the normal range to slightly above the normal range for the The study was repeated utilizing assayed whole blood hematocrit. controls from the same lot number seven (7) days after the first study .
WITHIN RUN PRECISION DATA
PHYSICIAN OFFICE # 1
Day One (Hematocrit)
Day Seven (Hematocrit)
| Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 | |
|---|---|---|---|---|---|---|
| 18.1 | 30.8 | 46.3 | X | 16.8 | 32.4 | 46.4 |
| .26 | .94 | 1.03 | SD | .77 | .63 | .63 |
| .01 | .03 | .02 | Cv | .04 | .02 | .02 |
| 15 | 15 | 15 | N | 15 | 15 | 15 |
PHYSICIAN OFFICE # 2
Day One (Hematocrit)
Day One (Hematocrit)
Day Seven (Hematocrit)
| Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 | |
|---|---|---|---|---|---|---|
| 17.9 | 33.5 | 46.1 | X | 17.4 | 32.7 | 47.7 |
| .70 | .52 | .74 | SD | .64 | .59 | .59 |
| .04 | .02 | .02 | Cv | .04 | .02 | .01 |
| 15 | 15 | 15 | N | 15 | 15 | 15 |
ALTERNATE SITE (BLOOD BANK) # 3
Day Seven (Hematocrit)
| Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 | |
|---|---|---|---|---|---|---|
| 18.6 | 33.7 | 47.3 | X | 18.8 | 33.4 | 47.5 |
| .51 | .88 | 1.11 | SD | .68 | .51 | .52 |
| .03 | .02 | .02 | Cv | .04 | .02 | .01 |
| 15 | 15 | 15 | N | 15 | 15 | 15 |
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JUN 22 1156 1.65 C.6.2.21 2.1.630 1.515 200
P.10/15
| PAGE G | |||||
|---|---|---|---|---|---|
| BETWEEN RUN PRECISION DATA | |||||
| Day One and Day 7 (Hematocrit) | |||||
| Physician Office #1 | $\overline{X}$ | SD | Cv | N | |
| Level 1 | 17.4 | .92 | .05 | 2 | |
| Level 2 | 31.6 | 1.13 | .04 | 2 | |
| Level 3 | 46.4 | .07 | <.01 | 2 | |
| Physician Office #2 | $\overline{X}$ | SD | Cv | N | |
| Level 1 | 17.6 | .35 | .02 | 2 | |
| Level 2 | 33.1 | .56 | .02 | 2 | |
| Level 3 | 46.9 | 1.13 | .02 | 2 | |
| Alternate Site BloodBank # 3 | $\overline{X}$ | SD | Cv | N | |
| Level 1 | 18.7 | .14 | .01 | 2 | |
| Level 2 | 33.6 | .21 | .01 | 2 | |
| Level 3 | 47.4 | .14 | <.01 | 2 |
Level 1,2,3 whole blood controls were Para 4 from Steck Laboratories Lot Numbers 61410065, 61410066, and 61410067 respectively. Hematocrib values(8) for Streck controls are 16 +3 or -3, 32 +4 or -4,and 47 +5 or -5 respectfully.
NOTE :
An additional precision study was performed in a typical laboratory with 10 whole blood samples run at each level, a total of five (5) levels were used. The range varied from the lower end of the Spuncrit to the highest end of the Spuncrit. this study was repeated of the same whole blood samples 13 days, after the first study.
Whole blood samples (5 levels, A through E) were run on Day 1 and Day 13. These samples were prepared from the same loc, run on two different dates (Day 1 and Day 13).
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WITHIN RUN PRECISION DATA
11 1 1 1 1 1 1
LABORATORY LOCATION
| DAY ONE (Hematocrit) | DAY 13 (Hematocrit) | |||||||
|---|---|---|---|---|---|---|---|---|
| X | SD | Cv | N | X | SD | Cv | N | |
| LEVEL A | 14.1 | .32 | .02 | 10 | 14.6 | .52 | .04 | 10 |
| LEVEL B | 29.3 | .48 | .02 | 10 | 30.3 | .67 | .02 | 10 |
| LEVEL C | 37.3 | .48 | .02 | 10 | 36.8 | .92 | .02 | 10 |
| LEVEL D | 53.6 | .58 | .01 | 10 | 52.5 | 1.51 | .02 | 10 |
| LEVEL E | 56.3 | .68 | .01 | 10 | 56.6 | .52 | .01 | 10 |
BETWEEN RUN PRECISION DUTS
LABORATORY LOCATION
DAY ONE and DAY THIRTERY (Hematockic)
| LEVEL A | ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ | X | |
|---|---|---|---|
| LEVEL B | " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " | ||
| LEVEL C | - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - | ||
| LEVEL D | ーーーーーーーーーーーーーーーー | ||
| LEVEL E |
CONCLUSION: Based on the above information it is believed that i
ccts are substantially equivalent and the would rh obsean. Based on the above information it is believed the
the two products are substantially equivalent and the reaults
Provided by the Spuncrit provide the same clinical and the Spuncrit provide the same clinical and the results
provided by the Spuncrit provide the same clinical ut lity as the
Compur M1100 Centrifuge for Hematocrit.
PAGE . H
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PAGE I
A6) Limitations of Procedure
- o Hematocrit
- o Estimated Hemoglobin
There are no known interfering substances that will interfere with the Hematocrit determination performed by the Spuncrit. However, severly hemolyzed blood should of the problem. Websiter, severly nemolyzed blood should
not be used in determining the Hematocrit by the Spuncric.
The range of the Spuncrit for Hematocrit is 14% to 57%. estimated Hemoglobin range is from 12.2 g/dL to 18.2 g/dL. The The estimated Hemoglobin only estimates Hemoglobin as a function of the PCV. The estimated Hemoglobin is not representative of anemic problems. As a result the Spunctit will only estimate the Hemoglobin for normal range only. Genetic Anemias or anemia caused by chronic disease states
will not be estimated will not be estimated.
§ 864.6400 Hematocrit measuring device.
(a)
Identification. A hematocrit measuring device is a system consisting of instruments, tubes, racks, and a sealer and a holder. The device is used to measure the packed red cell volume in blood to determine whether the patient's total red cell volume is normal or abnormal. Abnormal states include anemia (an abnormally low total red cell volume) and erythrocytosis (an abnormally high total red cell mass). The packed red cell volume is produced by centrifuging a given volume of blood.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9.